Skip to main content
OpenTrials
Completed

NCT Number: NCT04381637

Newborn Infant Parasympathetic Evaluation (NIPE) Index After Standardized Tetanic Stimulations Under General Anesthesia

NIPE monitor is the recently developed pediatric version of the ANI monitor, which is used in adults to monitor analgesia during general anesthesia. In adults, under general anesthesia, ANI decreases after a nociceptive stimulation. The amplitude of this decrease is related to the intensity of the stim. This study aims to investigate if NIPE index decreases in the same manner after stimulations in anesthetized children.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Anesthesia Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

6 year–10 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective surgery under general anesthesia requiring tracheal intubation and muscle relaxation
  • Written informed consent obtained from parents (and from child if appropriate)

Exclusion criteria

  • Thoracic or cardiac surgery
  • Cardiac arrhythmia, Pace maker
  • Analgesic medication less than 24 hours before surgery
  • Chronic anticholinergic medication
  • Contraindication to muscle relaxants or general anesthetics

Treatment and study plan

NIPE monitor

Device

NIPE monitor connected to the anesthetic station. No part of the device in contact with the patient. No action on patient or anesthesia. Automatic recording of Heart rate and NIPE index during the study period.

Tetanic stimulations

Procedure

Three tetanic stimulations will be performed (10-30 and 60 milliamps) under general anesthesia, before surgical incision.

Stims performed via the muscle relaxation monitor (used in standard practice in this population) Each stim lasts for 5 seconds. Interval between two stims : 3-5 minutes Order on intensities randomized by a latin square of order 3.

Primary outcomes

  1. Variation of NIPE index (∆NIPE)

    Time frame: 3 minutes following tetanic stimulation

    ∆NIPE = [NIPE minimal value in the 3 minutes following the stim] - [NIPE before stim]

    NIPE varies from 0 to 100. Monitor displays one value per second. NIPE index expected to decrease after stim.

Secondary outcomes

  1. Heart rate Variation (∆HR)

    Time frame: 3 minutes following tetanic stimulation

    ∆HR = [HR maximal value in the 3 minutes following the stim] - [HR before stim] Heart rate expected to increase after stim.

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Collaborators

  • Fondation Apicil

Registry information

Official study title

Newborn Infant Parasympathetic Evaluation (NIPE) Index After Three Standardized Tetanic Stimulations (10, 30 and 60 Miliamps) Performed in a Randomized Sequence Under General Anesthesia in a Pediatric Population

Acronym: NIPESTIM

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 11, 2020
Registry last updated
Jan 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.